Pharmaceutical advertising regulation and medical device advertising India

The legislative framework governing the advertising of medicines and medical devices in India is prescribed under the following laws:

1. Drugs and Cosmetics Act, 1940 (“Drugs Act”), the rules made under the Drugs Act (“Drugs Rules”) and the Medical Devices Rules, 2017 (“MD Rules”);
2. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMRA”) and the rules prescribed under DMRA (“DMRA Rules”);
3. The Consumer Protection Act, 2019 (“CPA”); 
4. Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 issued pursuant to the CPA (“2022 Guidelines”); and
5. Influencer Guidelines for Health and Wellness Celebrities, Influencers and Virtual Influencers, 2023 issued pursuant to the CPA (“Additional Guidelines”).

In addition to the above laws, the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers has published (a) the Uniform Code for Pharmaceutical Marketing Practices, 2024 (“UCPMP”); and (b) the Uniform Code for Marketing Practices in Medical Devices, 2024 (“UCMPMD”), to regulate the promotion and marketing of medicines and medical devices in India, respectively. 

In addition to the laws and regulations set out in paragraph 1 above, the following self-regulatory codes govern advertising of medicines and medical devices in India: 

1. The Advertising Standards Council of India (“ASCI”) is a self-regulatory body, which was established to ensure that advertisements in India are honest, decent, safe and fair. ASCI has issued the ASCI’s Code for Self-Regulation of Advertising Content in India (“ASCI Code”) which primarily (i) regulates ethical marketing practices, including marketing and promotion of medicine and medical devices to healthcare professionals (“HCP(s)”), (ii) requires truthful claims and representations to be made, and (iii) imposes restrictions on inducements and misleading advertisements as set out in the response to query 5 below.
2. The Organisation of Pharmaceutical Producers of India (“OPPI”) was established as an industry body which represents pharmaceutical companies in India. OPPI has issued a code of pharmaceutical practices (“OPPI Code”) which sets out practices and processes on advertisements of medicines which align with the UCPMP and the ASCI Code. 

Advertisement of drugs specified under Schedules H, H1 and X of the Drugs Rules (“Prescription Drugs”) require a prior approval of the Central Government. 

For any other medicines or medical devices other than Prescription Drugs (“OTC Drugs”), which have been approved for use under Drugs Act and the rules set out thereunder, no licenses/approvals/fees are required for advertisements addressed either to the general public or HCPs.

Prescription Drugs cannot be freely advertised to the public and as highlighted in the response to Query 3 above, any advertisement in connection with Prescription Drugs requires prior approval of the Central Government.

Conversely, OTC Drugs, and their advertisement is permissible subject to compliance with the requirements set out in the response to Query 5 below.

5.1 Medicines

Advertisements of medicines and medical devices in India must comply with general principles requiring them to be (i) the truthful and honest (ii) not offensive to generally accepted standards of public decency (iii) safeguard against the indiscriminate use of advertising for the promotion of products, which are regarded as hazardous to society or to individuals and (iv) observe fairness in competition 1  and as per the UPCMP any description, claim and comparison relating to matters of objectively ascertainable facts should be capable of substantiation. 2  

The key restrictions under various laws and regulations applicable in India are as follows: 

1. As mentioned above, Prescription Drugs cannot be advertised in India unless a prior approval has been obtained from the Central Government.
2. The DMRA and DMRA Rules regulate the advertisement of drugs to primarily prohibit advertisement of remedies that are alleged to possess magic qualities. They further prohibit: 
   1. advertisement of drugs intended for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder including drugs relating to (1) the procurement of miscarriage in women; (2) the prevention of conception in women; (3) maintenance or improvement of the capacity of human beings for sexual pleasure; (4) the correction of menstrual disorders in women; or (5) any disease, disorder or condition specified under the Schedule  3  to the DMRA Act and the DMRA Rules. 4  
   2. advertisement of magic remedies which directly or indirectly claim to be efficacious for any of the purposes restricted under sub-clause (i) above. 5
   3. misleading advertisements relating to drugs, including advertisements that directly or indirectly give a false impression regarding the true character of the drug, make false claims for the drug, or which are otherwise false or misleading in any particular material. 6
   4. import into and export out of India any documents containing such advertisements prohibited under sub-clause (i) above.
3. The Drugs Act and the related rules regulate the import, manufacture, distribution and sale of medicines and medical devices in India and restrict advertisements: 
   1. which are false or misleading.
   2. make a claim to prevent or cure or convey any idea that a medicine or a medical device may prevent or cure any of the diseases or ailments specified under Schedule J of the Drugs Rules. 7 Further as per the Drugs Act, for advertisement of any substances specified under Schedule C 8  (Biological and Special Products) of the Drugs Rules, the ‘proper name’ (as defined in Schedule F of the Drugs Rules. 9 ) of such substance is required to be mentioned.
4. The CPA and the 2022 Guidelines broadly contain restrictions for the prevention of false and misleading advertisements in India. These require advertisements to: (i) be valid and non-misleading (particularly as to its scientific validity, practical usefulness, risks, personal security etc.), 10  (ii) not constitute bait advertising (seeking to entice consumers to purchase medicines or medical devices without a reasonable prospect of selling the advertised medicine or medical device or intending to mislead consumers about availability or market conditions); and (iii) not be prohibited under any applicable law. 11
5. The UCPMP and UCMPMD set out permitted marketing practices for medicine and medical devices and have the following restrictions: 
   1. Brand names of products of other companies cannot be used in comparison by a company unless the prior consent of the concerned company has been obtained. Further, products or services of other companies and clinical/scientific opinions of HCPs cannot be disparaged. 12
   2. Promotional material such as mailings and journal advertisements cannot be designed to disguise their real nature and where a pharmaceutical company pays for or otherwise secures or arranges the publication of some promotional material in journals, such promotional material must not resemble the editorial matter. 13
   3. The names or photographs of HCPs cannot be used in advertisements. 14
6. Separately, the Hon’ble Supreme Court of India in its 2024 judgment in the case of Indian Medical Association v. Union of India 15 , issued directions on misleading advertisements and required advertisers to submit self-declarations on a portal operationalized by the Ministry of Information and Broadcasting (“MIB”). Further requirements under this decision have been set out in our responses to Query 11 below.

5.2 Medical devices

For the relevant requirements concerning medical devices, please refer to our responses to Query 5 above, given that the regulatory framework and associated compliance obligations are broadly consistent with and similar to those applicable to medicines. 

The UCMPMD and UCPMP prescribe restrictions on extending benefits or advantages to HCPs which could influence the prescription of medicine or medical device by such HCP. Such practices are regarded as improper inducements and are contrary to the tenets of ethical marketing.

6.1 Medicines

1. Pharmaceutical companies and their agents are restricted from offering gifts, travel facilities, hospitality, cash or monetary grants, brand reminders (books, calendars, dummy devices etc) exceeding the value of INR 1,000 (i.e., ~Euro 10) per item 16  to HCPs. Similarly, HCPs under Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 are also prevented from availing of these gifts/facilities. 17
2. Medical representatives can only provide free samples of medicines for professional evaluation, subject to the following conditions: (i) free samples need to be limited to the prescribed dosage for not more than three patients and not more than twelve sample packs should be provided to a HCP in a year; (ii) the samples must not be larger than the smallest commercial pack of the medicine and must be marked to indicate that it is a ‘free sample not for sale’; and (iii) free samples of hypnotic, sedative or tranquillizer drugs cannot be provided to a HCP. 18

6.2 Medical devices

The UCMPMD imposes similar restrictions on medical device companies. However, given the inherent nature of devices is different than medicines, the restriction on providing samples is different and such companies are allowed to provide ‘free units’ of medical devices subject to the following restrictions:

1. Evaluation units: Evaluation units of a medical device may be supplied only in limited quantities to healthcare professionals for clinical assessment and familiarisation along with the user manual. The quantity provided must be reasonable for evaluation and the total value of such units distributed by the company must not exceed 2% of its annual domestic sales. Each unit should be marked ‘Evaluation Sample – Not for Sale’ and records of the recipient, quantity and value must be maintained by the company (providing such devices for evaluation) for a minimum of five years.
2. Demonstration units: Demonstration units of medical devices can be provided to a healthcare professional, solely to illustrate the functioning of the device during training or educational interactions and must not act as a substitute for purchase or an inducement. Ownership of demonstration units should always remain with the company, and the unit must be retrieved by the company after demonstration. Additionally, appropriate records indicating the recipient, quantity and value must be maintained by the company (providing such devices for demonstration) for a minimum of five years.

While the information required to be included in advertisements directed to the general public is more extensive and discussed in further detail in our response to Query 8 below, our response to this query focuses solely on the exclusive requirements applicable to advertisements addressed to HCPs, which are governed by UCPMP. 

Notwithstanding this distinction, the substantive restrictions applicable to advertisements addressed to the general public, particularly those prohibiting false, misleading, exaggerated, or unsubstantiated claims, apply equally to advertisements directed at HCPs.

7.1 Medicines

1. The UCPMP sets out the minimum information which should be included in advertisements directed towards HCPs: (i) the name and address of the holder of marketing authorisation of the drug; (ii) the brand name together with the generic name(s) of the active ingredient(s); (iii) the recommended dosage, method of use and route of administration; (iv) adverse reactions, warnings, precautions and a statement that further information is available on request, together with the date of preparation; and (v) the date of printing, wherever technical and informative material is used. 19
2. Additionally, advertisements must not (i) be misleading and confusing; 20  (ii) feature the names or photographs of HCPs; 21  and (iii) be designed in a manner that disguises the real nature of the material. 22

7.2 Medical Devices

Under the MD Rules, 2017, advertisement of medical device is required to be consistent with the device’s Central Drugs Standard Control Organisation (“CDSCO”) approved intended use. 23

Additionally, the minimum information for the promotion of the medical devices under the UCMPMD must clearly include: (i) the generic and/ or brand name of the medical device; (ii) the name and address of the manufacturer or importer and the entity responsible for marketing the device; (iii) warnings, precautions and relevant contraindications; (iv) a statement that additional information is available on request; and (v) the date on which the abovementioned particulars were generated or last updated. 24

As set out in our response to Query 5, public advertising of medicines and medical devices is primarily governed through statutory prohibitions. Accordingly, Indian law does not prescribe a detailed list of mandatory disclosures for advertisements addressed to the general public; rather, compliance is ensured by restricting the nature and content of permissible claims. 

8.1 Medicines

In addition to the prohibitions discussed in Query 4 and Query 5 above on the advertisement of medicines, advertisements directed to the general public must not claim efficacy for diseases mentioned in Schedule I of the DMRA or create a misleading impression about their therapeutic benefits. 25

The 2022 Guidelines issued by the Central Consumer Protection Authority (“CCPA”) set out general standards for valid advertisements across all product categories, and these requirements apply equally to advertisements for medicines and medical devices. As per the 2022 Guidelines, an advertisement should (i) contain true and honest representation; (ii) not exaggerate the accuracy, scientific validity, practical usefulness, capability or performance of the product; (iii) not present rights conferred on consumers by any law as a distinct feature of the advertiser’s offer; (iv) not suggest universal acceptance of claims where significant scientific or informed opinion is divided; (v) not mislead regarding risks to personal security or create undue fear to induce purchase; (vi) not rely on unsubstantiated claims based merely on publications; and (vii) comply with applicable sector-specific laws and regulations. 26

8.2 Medical Devices

For the relevant requirements concerning medical devices, please refer to the immediately preceding paragraph, given that the regulatory framework and associated compliance obligations are broadly consistent and similar to those applicable to medicines.

Indian law does not prescribe a specific evidentiary standard or a rigid hierarchy of scientific data (e.g., prohibiting data on file, subgroup or retrospective analyses, or meta-analyses as categories per se) for promotional claims relating to medicines or medical devices. However, the DMRA prohibits participation in the publication of any advertisement that makes false claims, creates a misleading impression about the nature of the drug, or otherwise contains deceptive statements. 27

The UCPMP and UCMPMD require the promotional claims to be grounded in a balanced and verifiable evaluation of all available evidence and accurately reflect current scientific knowledge or responsible medical opinion. 28  Information presented in advertisements should be verifiable and the claims of usefulness must rely on up-to-date scientific evidence. 29  Absolute safety claims or claim of no adverse effect are prohibited. 30

Under the ASCI Code, advertisements for medicines and medical devices must adhere to the overarching requirement of truthfulness, honest representation and verifiability. Scientific or research-based claims must disclose the source and date of such research wherever relied upon, and advertisements must not distort facts, omit material limitations, exaggerate efficacy, or otherwise mislead consumers either expressly or by implication. 31

Under the ASCI Code, comparative advertisements are allowed only if: (i) the basis of comparison is clear; (ii) the comparison is factual, accurate and substantiated; (iii) it does not mislead consumers; and (iv) it does not unfairly denigrate competing products or companies. 32

Similarly, the UCPMP and UCMPMD require comparisons to be fair, balanced and capable of substantiation. Further, the advertisement must not mislead through distortion, omission, or undue emphasis. Competitor brand names may be used only with prior consent, and competing products or professional opinions must not be disparaged directly or indirectly. 33

India does not have a standalone statute exclusively governing online or social-media advertising of medicines and medical devices. Instead, digital promotion is regulated through laws (as discussed in our response to Query 1 and Query 2), which apply irrespective of the medium of dissemination. 

While advertising medicines on the internet/ in social media postings is generally permitted, this does not extend to prescription-only medicines. Prescription Drugs are subject to advertising restrictions and any advertisement in respect of such medicines requires the prior sanction of the Central Government.

Statutory restrictions under pharmaceutical laws such as the Drugs Act and the DMRA, apply equally to digital advertisements. The Hon’ble Supreme Court of India has also clarified that the term ‘advertisement’ under the DMRA extends beyond print and television to all forms of communication, including electronic media, thereby prohibiting therapeutic claims for diseases mentioned in Schedule I of the DMRA. 34

The 2022 Guidelines also extend to advertisement through electronic media, the internet or websites, thereby bringing online advertisements within its scope. 35  Further, the Additional Guidelines impose restrictions on digital promotion of medicines and medical devices. The Additional Guidelines require social media influencers presenting themselves as health experts or medical practitioners to undertake due diligence, endorse only permissible products and provide clear disclaimer that the content is not a substitute for professional medical advice. 36

Additionally, pursuant to a notification issued by the MIB 37 , and in compliance with directions of the Hon’ble Supreme Court of India on misleading advertisements, advertisers and advertising agencies are required to submit a prior self-declaration certificate through the Broadcast Seva Portal of the MIB (for TV and radio advertisements) and through the Press Council of India Portal (for print and digital media advertisements) affirming that the advertisement does not make misleading claims and complies with all relevant regulations, before publishing advertisements relating to food, drugs, medical devices and health services. 

Further, the self-regulatory ASCI Code mandates that social media promotions published on the media company handles must be clearly distinguishable from editorial or other content. These promotional social media posts must carry disclosures at the beginning using labels such as ‘Advertisement’ or ‘Ad’. 38  The ASCI Code also requires such social medial influencers to disclose relevant professional qualifications. In the absence of such qualifications, they may only share generic, non-technical information and must not provide medical or therapeutic advice. 39

Enforcement of rules governing advertisements for medicines and medical devices in India is multi-layered and involves authorities constituted under the various legislations discussed above. 

Drugs Act and DMRA: Primary enforcement under the Drugs Act and DMRA is overseen by the Drugs Controller General of India appointed under the CDSCO. Violations under these statutes may attract criminal liability. In particular, under the DMRA, publication of prohibited or misleading advertisements may result in imprisonment of up to six months for a first offence and up to one year for subsequent offences, or fine, or both.

CPA: Misleading advertisements may additionally be examined by the CCPA under the CPA. The CCPA is empowered to investigate advertisements, order their discontinuation or modification, and impose monetary penalties on manufacturers and endorsers. The penalties may extend up to INR 1 million (~EUR 10,000) for a first contravention and up to INR 5 million (~EUR 50,000) for subsequent violations.

Self-Regulation: At the industry level, complaints may be reviewed under the UCPMP and the UCMPMD through designated committees and appellate bodies, which may recommend corrective measures or refer matters to statutory regulators. The ASCI may also issue notices to advertisers and influencers and direct modification or withdrawal of non-compliant material. While ASCI’s decisions are not statutorily enforceable, non-compliance may result in reputational consequences, withdrawal of advertisements, suspension or expulsion from industry associations, and escalation to statutory authorities such as the CCPA.

India’s regulations for medicines and medical devices are evolving toward a more consolidated and centralized framework. The following are the key development expected in the future:

1. Legislative reform has been proposed through the draft Drugs, Medical Devices and Cosmetics Bill, 2022, 40  intended to replace the Drugs Act. The draft legislation contemplates a unified regulatory framework covering drugs, medical devices and cosmetics and is expected to enable more structured supervision of promotional practices across product categories.
2. Online sale and promotion of medicines are expected to be specifically regulated through the E-Pharmacy Rules, 2018. The draft rules explicitly prohibit e-pharmacies from advertising drugs on media platforms for any purpose. 41  
3. With the objective of strengthening the regulatory framework against advertisements containing misleading health claims, particularly in relation to lifestyle diseases, the Central Government, in 2020, proposed an amendment to the DMRA to expand the list of prohibited diseases, disorders, or conditions from 54 to 78. The list specifies the diseases, disorders, or conditions in respect of which the DMRA prohibits any advertisement. Although the proposed amendment has not yet been formally notified and is therefore not in force, further developments and notification in this regard are anticipated as part of the Government’s continuing efforts to further tighten the regulatory framework. 42
4. The Drug Consultative Committee (“DCC”) of the CDSCO has examined the need for a clearer regulatory framework to control the widespread and unchecked advertisement of prescription only and potent drugs. In this context, DCC is deliberating on extending the existing prohibition on advertisement of prescription only and potent drugs which currently applies only to manufacturers, to also cover licensees engaged in sale or distribution of specified prescription drugs. 43